EQS-News: Horus Pharma becomes additional commercialization partner for Formycon's Eylea® biosimilar FYB203 in selected European countries under the brand name Baiama®

Press Release // September 17, 2025
 

Horus Pharma becomes additional commercialization partner for Formycon's Eylea^® biosimilar FYB203 in selected European countries under the brand name Baiama^®
 

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon”) announces that Klinge Biopharma GmbH (“Klinge”), the exclusive owner of the global commercialization rights of Formycon's Eylea^®1 biosimilar FYB203 (aflibercept), concluded an additional semi-exclusive license agreement with Horus Pharma (“Horus”) for the commercialization of FYB203/Baiama^®2 in selected European countries. The agreement follows the semi-exclusive partnership signed in January with Teva Pharmaceuticals International GmbH (“Teva”) for the commercialization of FYB203/AHZANTIVE^®3 covering major parts of Europe and Israel.

Upon signature, Klinge is eligible to receive upfront and milestone payments, plus royalties on net sales. Formycon will participate in the mid-single-digit to low-double-digit percentage range in all payment streams to Klinge resulting from these agreements. Furthermore, Formycon will act as authorized designee to organize the supply chain for FYB203 and will receive additional service payments and a volume-based profit component for organizing the commercial market supply^{on behalf of Klinge.}

Aflibercept is used to treat neovascular age-related macular degeneration (nAMD), the leading cause of blindness and visual disability in patients aged over 60 years in Europe and North America, as well as other severe retinal diseases.

Nicola Mikulcik, CBO of Formycon AG says: “We are very pleased that we could add Horus Pharma, a distinguished specialist in ophthalmology, to the group of our excellent commercial partners. Horus will market the brand Baiama^® in selected European markets including its home market France. Baiama^® will be sold as a second brand in addition to AHZANTIVE^®, which will be launched by Teva across Europe. Teva is already successfully marketing our Lucentis^®4 biosimilar Ranivisio^®5. With our two-brand-partner strategy we are striving for the best possible therapeutic coverage to fully leverage the high market potential in Europe.”

Horus Pharma is the second largest independent ophthalmological laboratory in France and a leading player in Europe. For more than 20 years, the independent laboratory has been recognized for its know-how in developing preservative-free products in ophthalmology. Thanks to a sustained Research & Development policy, Horus Pharma is improving the daily lives of patients by developing and distributing solutions and products for all segments of eye health.

In June 2024, the aflibercept biosimilar FYB203 was approved by the US Food and Drug Administration (“FDA”). Approval by the European Commission under the brand names AHZANTIVE^® and Baiama^® followed in January 2025.^{One month later, FYB203 also received marketing authorization by the British MHRA.6}

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1)  Eylea® is a registered trademark of Regeneron Pharmaceuticals Inc.
2)  Baiama® is a registered trademark of Klinge Biopharma GmbH
3)  AHZANTIVE® is a registered trademark of Klinge Biopharma GmbH
4)  Lucentis® is a registered trademark of Genentech Inc.
5)  Ranivisio® is a registered trademark of Bioeq AG
6)  The commercial launch of FYB203 in Europe depends on the progress and outcome
     of ongoing or potential future patent litigation or possible settlement agreements.

Alira Health has acted as strategic advisor to Klinge and Formycon
in the transaction with Horus Pharma.

About Formycon:
Formycon AG (FSE: FYB) is a leading, independent developer of high-quality biosimilars, follow-on products of biopharmaceutical medicines. The company focuses on therapies in ophthalmology, immunology, immuno-oncology and other key disease areas, covering almost the entire value chain from technical development through clinical trials to approval by the regulatory authorities. For commercialization of its biosimilars, Formycon relies on strong, well-trusted and long-term partnerships worldwide. With FYB201/ranibizumab and FYB202/ustekinumab, Formycon already has two biosimilars on the market. Another biosimilar, FYB203/aflibercept, has been approved by the FDA, EMA, and MHRA. Four pipeline candidates are currently in development. With its biosimilars, Formycon is making an important contribution to providing as many patients as possible with access to highly effective and affordable medicines.

Formycon AG is headquartered in Munich, listed in the Prime Standard of the Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY and is part of the SDAX and TecDax selection indices. Further information can be found at: https://www.formycon.com/

About Horus Pharma
Founded in 2003, Horus Pharma is an independent laboratory, leader in the French and European markets, recognized for its know-how in developing preservative-free products in ophthalmology. Thanks to a sustained Research & Development policy, Horus Pharma is improving the daily lives of patients by developing innovative solutions and products for all segments of eye health. Horus Pharma distributes its products in France – headquartered in Nice – and internationally through its subsidiaries in Belgium, the Netherlands, Luxembourg, Spain, Switzerland, and the Nordic countries. It has investments in Romania and distribution agreements in Western and Eastern Europe, North Africa, South East Asia, the Near and Middle East, ensuring a presence in more than 30 countries.

More information at www.horus-pharma.com

About Biosimilars:
Since their introduction in the 1980s, biopharmaceutical drugs have revolutionized the treatment of serious and chronic diseases. By 2032, many of these drugs will lose their patent protection – including 45 blockbusters with an estimated total annual global turnover of more than 200 billion US dollars. Biosimilars are successor products to biopharmaceutical drugs for which market exclusivity has expired. They are approved in highly regulated markets such as the EU, the USA, Canada, Japan and Australia in accordance with strict regulatory procedures. Biosimilars create competition and thus give more patients access to biopharmaceutical therapies. At the same time, they reduce costs for healthcare systems. Global sales of biosimilars currently amount to around 21 billion US dollars. Analysts assume that sales could rise to over 74 billion US dollars by 2030.

Contact:
Sabrina Müller
Director Investor Relations and Corporate Communications
Formycon AG
Fraunhoferstr. 15
82152 Martinsried/Planegg
Germany

phone +49 (0) 89 - 86 46 67 149
fax + 49 (0) 89 - 86 46 67 110
Sabrina.Mueller@formycon.com

Disclaimer:
This press release may contain forward-looking statements and information which are based on Formycon’s current expectations and certain assumptions. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, performance of the company, development of the products and the estimates given here. Such known and unknown risks and uncertainties comprise, among others, the research and development, the regulatory approval process, the timing of the actions of regulatory bodies and other governmental authorities, clinical results, changes in laws and regulations, product quality, patient safety, patent litigation, contractual risks and dependencies from third parties. With respect to pipeline products, Formycon AG does not provide any representation, warranties or any other guarantees that the products will receive the necessary regulatory approvals or that they will prove to be commercially exploitable and/or successful. Formycon AG assumes no obligation to update these forward-looking statements or to correct them in case of developments which differ from those anticipated. This document neither constitutes an offer to sell nor a solicitation of an offer to buy or subscribe for securities of Formycon AG. No public offering of securities of Formycon AG will be made nor is a public offering intended. This document and the information contained therein may not be distributed in or into the United States of America, Canada, Australia, Japan or any other jurisdictions, in which such offer or such solicitation would be prohibited. This document does not constitute an offer for the sale of securities in the United States.